Medicare's Noncovered Conditions by robertinseattle

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  MEDICARE’S NONCOVERED CONDITIONS;
                      A Conversation With Dr. George B. Hart
                                                          by David Freels


     Editorʼs Notes
     The following article recounts a phone conversation between      naming names) but he first had several loose ends to tie up.
     Dr. George Hart and David Freels in August of 2000. The          I called Dr. Hart back two weeks later to discuss this again
     phone conversation was intended to be information for David      and he told me he had accepted a position back at Long
     Freels’ legal case and not intended to be an investigational     Beach Memorial Hospital and had changed his mind about
     article on sickle cell anemia or anything else. After David      the article and didn’t want to discuss it any further. This was
     Freels had this amazing conversation he called me to ask         so abrupt that I continued over the next few years trying to
     if I knew anything about Dr. Hart or the “Noncovered”            persuade him as a medical professional, as a Naval officer,
     indications. I told Mr. Freels that I knew Dr. Hart but was      and as a concerned citizen, to please come forward and
     not aware how involved he was with the creation of the list.     correct this terrible injustice. I spent countless hours on the
     I told David I was very interested in hearing Dr. Hart’s story   phone, sending E-mails, pleading with him to go public with
     because if there was any truth to it, it would change our field   his story.
     and answer the age old question “what is it that is holding
     hyperbarics back?”                                               I can affirm that through my phone conversations and E-
                                                                      mails that everything David Freels has reported here was
     I called Dr. Hart in September of 2000 to check Mr. Freels’      also reported to me by Dr. Hart. We are publishing one of the
     story. I did not tell Dr. Hart that I spoke with David but       letters Dr. Hart wrote to David to verify this conversation
     rather pursued a line of questioning about the Medicare          and its original purpose (sickle cell anemia and the other
     “Noncovered” conditions. Dr. Hart confirmed every thing           “Noncovered indications”).
     David Freels writes here and told me that he had been waiting
     30 years for someone to ask him about the “Noncovered”           I have appealed to Dr. Hart on every level to please come
     indications. This article has been three years coming because    forward with his story. He has refused, telling me “I will let
     Mr. Freels and I have both, slowly over time, tried to appeal    my peers judge me on my accomplishments.”
     to Dr. Hart to come forward with the complete details of who
     told him to suppress these indications or take the position      These are the events as relayed from David Freels in a phone
     he did. My first conversation ended with Dr. Hart telling me      conversation in August of 2000 from his notes.
     he would give me a complete account for publication (i.e.




My wife and I first requested Medicaid          14 “Covered Conditions” of HBOT and 22         studies & references for each “Noncovered
reimbursement for our son Jimmy in 1999.       “Noncovered Conditions”. According to the      Condition AND hyperbaric”. The number
Jimmy suffers from mid-brain injury but like   Ethics Committee report of the Undersea        of references appears in parentheses. I
95% of all brain-injured children, he made     and Hyperbaric Medical Society (UHMS),         was surprised to learn there was so much
tremendous gains with Hyperbaric Oxygen        the “Noncovered” list is equivalent to an      evidence on HBOT and its efficacy for
Therapy. After three denials between May       off-label uses list.                           nearly everything on the “Noncovered”
and December, 1999, we requested a hearing     It occurred to me that maybe Georgia           list.
before an Administrative Law Judge (ALJ).      Medicaid      had    already    reimbursed
Our first hearing date was July 6, 2000 and     HBOT for one of the other “Noncovered          According to Section 35-10B of the
scheduled to reconvene in late September,      Conditions”, which would set a precedent       Medicare Coverage Issues Manual, “No
2000. The whole issue was about accessing      and open the door for us to also access off-   program payment may be made for HBO in
off-label HBOT. A big problem was Georgia      label hyperbaric oxygen therapy.               the treatment of the following conditions:”
Medicaid was following Medicare policy
on HBOT reimbursement. Medicare has            For this article I did a Medline review of

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1. Cutaneous, decubitus, and stasis ulcers.   2000, my U.S. Representative was Cynthia        Then Dr. Hart said; “Hyperbaric oxygen
   (176 Medline references)                   McKinney, always a very outspoken critic        also works for sickle cell priapism.
2. Chronic peripheral vascular                of the US government and some would say
   insufficiency. (50 Medline references)      particularly partisan when it comes to any      David Freels: “Whatʼs that?”
3. Anaerobic septicemia and infection         and all issues involving African-Americans.
   other than clostridial.                    I wanted to present the sickle/HBOT data        Dr. Hart:
  (84 Medline references)                     to Cynthia McKinney so she would in turn        “The penis stays in a perpetually erect state
4. Skin burns (thermal).                      light a fire under Georgia Medicaid to treat     at two or thee times its normal size. It stays
   (42 Medline references)                    sickle cell kids with off-label HBOT.           that way for weeks and even months at a
5. Senility. (3 Medline references)                                                           time. Most of the time they die and nothing
6. Myocardial infarction. (heart attack)      Then, once we returned to our hearing we        can be done.”
   (110 Medline references)                   could point out that Georgia Medicaid was
7. Cardiogenic shock. (heart pumping          already treating children with off-label        David Freels: “Youʼre kidding.”
   is inadequate) (15 Medline references)     hyperbaric oxygen. First I had to get sickle
8. Sickle cell anemia. (sickle-shaped red     documentation, but I had no idea where to       Dr. Hart:
   blood cells block circulation)             look. I started with a post on the old HBO      “No, itʼs a despicable disease. We treated
   (16 Medline references)                    chat room. I received several responses, and    a priapism case with 2 atmospheres
9. Acute thermal and chemical pulmonary       each one said a Dr. George Hart had done        hyperbaric oxygen twice a day in a
   damage, i.e., smoke inhalation with        some research on sickle cell and hyperbaric     monoplace chamber. It was completely
   pulmonary insufficiency.                    oxygen.                                         resolved in 2 weeks and the patient had
   (77 Medline references)                                                                    been hospitalized for over 9 months for
10. Acute or chronic cerebral vascular        Members of the chat room said that Dr.          this. Theyʼd given the patient I donʼt know
    insufficiency. (118 Medline references)    Hart was at Long Beach Memorial Hospital        how many transfusions.”
11. Hepatic necrosis.                         in San Diego. I searched the internet,          “Iʼve also used hyperbaric oxygen therapy
   (7 Medline references)                     got a phone number, called and left a           for sickle cell hematuria.”
12. Aerobic septicemia.                       series of voicemails. After receiving no
   (2 Medline references)                     responses to my inquiries, I called again.      David Freels: “Hematuria?”
13. Nonvascular causes of chronic brain       Still no reply. I called thirteen more times.
    syndrome (Pickʼs disease, Alzheimerʼs     Finally somebody answered and said they         Dr. Hart:
    disease, Korsakoffʼs disease).            would give my number to Dr. Hart. I             Blood in the urine. Again, 2 atmospheres
   (6 Medline references)                     waited. Two weeks, maybe three. I called        hyperbaric oxygen twice a day in a
14. Tetanus. (36 Medline references)          back. A secretary answered and said she         monoplace chamber. Resolved in 3 days. “
15. Systemic aerobic infection.               remembered my 15 previous calls. She said       “Whatʼs your interest in sickle cell
   (39 Medline references)                    she had given my message to Dr. Hart, but       anemia?
16. Organ transplantation.                    he was retired. I scoured the Internet and      Are you a physician?”
   (192 Medline references)                   came across his home number and I left him
17. Organ storage. (13 Medline references)    a message. No responses, so I called back.      David Freels:
18. Pulmonary emphysema.                      I called again later that day and Mrs. Hart     “Uh, no sir. This might sound kind of
   (18 Medline references)                    answered and she got him on the phone.          confusing. I donʼt know if you know this, but
19. Exceptional blood loss anemia.                                                            Hyperbaric Oxygen Therapy is governed by
   (82 Medline references)                    He said heʼd take the call “downstairs, in my   the Health Care Financing Administration-
20. Multiple Sclerosis.                       office.” He sounded nice. Gentle. Patient.       -you know, HCFA. See, HCFA has this
   (96 Medline references)                    Kind. The warmth in his voice surrounded        list of what they call ʻcovered indicationsʼ
21. Arthritic Diseases.                       like an authority built on a lifetime of        for hyperbaric oxygen. For some strange
   (38 Medline references)                    experience. He had done work on sickle cell     reason they have a second list too. Itʼs titled
22. Acute cerebral edema.                     and hyperbaric oxygen therapy. In 1991 the      ʻNoncovered Conditionsʼ and says, ʻNo
   (24 Medline references)                    Journal of Hyperbaric Medicine published        program payment may be made for HBO in
                                              his “Amelioration of Sickle Cell Crisis         the treatment of the following conditionsʼ.
When I first reviewed the “Noncovered          With Intensive Hyperbaric Oxygen.”              Number 8 on the “Noncovered” list is
Conditions” list in July, 2000, the eighth                                                    ʻsickle cell anemiaʼ.”
one down caught my eye. Sickle cell           Paragraph 5 of the Medicaid law says
anemia. People of color, people of African    kids must have whatever is “necessary to
descent get sickle cell. I live in Dekalb     correct or ameliorate” and the first word        Dr. Hart:
County, Georgia--which is predominantly       in Dr. Hartʼs paper was Amelioration. This      “Thatʼs true, but whatʼs your interest in
African-American. In the summer of            was perfect.                                    sickle cell anemia?”

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                                                   Dr. Hart: “Iʼm doing this.”                   Dr. Hart: “How do you know that?”
     David Freels:
     “Iʼm not so much interested in sickle cell    David Freels:                                 David Freels:
     as Iʼm interested in the “Noncovered” list.   “Are you seeing some good results?”           “We talk. Itʼs taken me awhile to track
     Iʼm actually more interested in number                                                      you down. Youʼre a hard man to get a hold
     10, ʻacute or chronic cerebral vascular       Dr. Hart: “I canʼt say.”                      of. Dr. Harch knows a lot of people, and
     insufficiencyʼ. You see my wife and I are                                                    I figured he might know you, so I asked
     the parents of a brain-injured child. Heʼs    David Freels:                                 him.”
     had 42 treatments of hyperbaric oxygen,       “How many treatments have you done?”
     and weʼd like to get him some more.” (see                                                   Dr. Hart: “How do you know Harch?”
     Volume I, Issue VI, p.33)                     Dr. Hart:
     There was a pause.                            “Weʼre about half way through.”               David Freels:
                                                                                                 “Dr. Harch spoke as an expert witness at
     Dr. Hart:                                     David Freels:                                 our first Medicaid hearing date a few weeks
     “How did your son do with the HBO?”           “No kidding. Thatʼs great. Youʼre seeing      ago.”
                                                   some good stuff then, huh?”
     David Freels: “He did great.”                                                               Dr. Hart: “Medicaid?”
                                                   Dr. Hart: “I canʼt say.”
     Dr. Hart: “Like what?”                                                                      David Freels:
                                                   David Freels:                                 “Jimmy is a Medicaid recipient because
     David Freels:                                 “Thatʼs okay. I know you are.”                of his, uh, situation, and according to
     “Much better speech. Greatly improved                                                       the federal Medicaid law for children,
     fine motor skills. On Fatherʼs Day he said,    Dr. Hart: “How do you know that?”             Georgia Medicaid should be paying for
     ʻLook Dad,ʼ and stabbed a bean with his                                                     more hyperbaric oxygen. Theyʼve denied
     fork and then put it in his mouth. He can     David Freels:                                 us because they go by Medicareʼs HBO
     now feed himself for the first time. He        “Itʼs something like over 90% of every        policy.”
     used to speak in two-word couplets. Now       kid who gets HBO has some kind of
     he talks in sentences. Paragraphs even. He    improvement. Some say itʼs closer to          Dr. Hart:
     initiates conversation.”                      95%.”                                         “Are they saying itʼs experimental and
                                                                                                 investigational?”
     Dr. Hart: “Hmm. What was your                 Dr. Hart: “Who says that?”
     protocol?”                                                                                  David Freels:
                                                   David Freels: “Dr. Harch. Paul Harch.”        “And not medically necessary, and not the
     David Freels:                                                                               standard of medical practice .”
     “One hour at one point seven five              Dr. Hart: “You know Dr. Harch?”
     atmospheres, once a day, five days a week.                                                   Dr. Hart: “Theyʼre right.”
     He had 42 treatments. We did SPECT scans      David Freels:
     too.”                                         “Heʼs great. I think he ought to get the      David Freels:
                                                   Nobel Prize.”                                 “Yeah, but thatʼs not what the Medicaid
     Dr. Hart: “What did the SPECT show?”                                                        law says.”
                                                   Dr. Hart:
     David Freels:                                 “Harch isnʼt going to get credit for this.”   Dr. Hart: “Whatʼs it say?”
     “His cerebral       blood   flow   improved
     25.4%.”                                       David Freels:                                 David Freels:
                                                   “I thought you said it wasnʼt working?”       “It says, here Iʼll read it to you. These kids
     Dr. Hart:                                                                                   are supposed to get ʻsuch other necessary
     “Weʼre doing a double-blind controlled        Dr. Hart:                                     health care, diagnostic services, treatment,
     study of hyperbaric oxygen on cerebral        “I didnʼt say that. I just said I couldnʼt    and other measures to correct or ameliorate
     palsy.”                                       say.”                                         defects and physical and mental illnesses
                                                                                                 and conditions discovered by the screening
     David Freels:                                 David Freels:                                 services, whether or not such services are
     “Really? I thought you were retired.”         “You just did. You know Dr. Harch is a big    covered under the State plan.ʼ”
     There was a slight pause.                     admirer of yours.”
                                                                                                 Dr. Hart: “So?”


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                                                 “Really. I used to be president of the            “Who was this who gave you the order?”
David Freels:                                    UHMS.”
“It doesnʼt say ʻmedically necessaryʼ; it                                                          Dr. Hart:
says “whatever is...necessary to correct or      David Freels:                                     “I canʼt say, but youʼd recognize the name
ameliorate.”                                     “Where did the second list come from, the         if I told you. Listen, Iʼve treated so many
                                                 “Noncovered” list?”                               retired Navy officers whoʼve stroked. Iʼve
Dr. Hart:                                                                                          put them in the chamber and theyʼve made
“Hmmm. So whatʼs sickle cell got to do           Dr. Hart: “It came from me.”                      a complete recovery.”
with this?”
                                                 David Freels: “Youʼre kidding. Why?”              David Freels:
David Freels:                                                                                      “So Hyperbaric Oxygen Therapy works for
“The hearing reconvenes the latter part of       Dr. Hart:                                         stroke?”
September 2000, and Iʼm trying to get ready      “I told Social Security that I didnʼt want
for it. See, I live in Atlanta, and thereʼs      to be on the committee, but they kept             Dr. Hart:
probably a 65% black population here. My         asking. So finally I said yes. Under one           “Of course it works. It works for stroke
congress-person is a lady named Cynthia          condition.”                                       better than just about anything else, except
McKinney, whoʼs very good at bringing in                                                           maybe DCS.”
national and international media attention       David Freels: “What?”
to any situation or circumstance where she                                                         David Freels: “DCS?”
feels black people are exploited; particularly   Dr. Hart:
by the government. I think she does lunch        “They let me add the “Noncovered” list.”          Dr. Hart:
with Louis Farrakhan. Iʼd like to bring this                                                       “Decompression sickness. The bends. It
sickle cell and hyperbaric oxygen thing to       David Freels: “Why?”                              hits scuba divers. Listen, if they made HBO
her attention, that way some other Georgia                                                         available for everything it works for, three-
Medicaid kids can get some off label HBO         Dr. Hart:                                         fourths of the nursing homes in this country
from the “Noncovered” list and we can use        “Because one day this guy came to my              would shut down inside of six months.
that in our hearing. You know, whatʼs good       office. He was a very, very, very senior           Everybody would go home. They wouldnʼt
for the goose is good for the gander.”           government official, whose name you                need them. It works for stroke, MS,
                                                 would recognize. He came into my office            Parkinsonʼs, Alzheimerʼs--Alzheimerʼs, let
Dr. Hart:                                        and pointed his finger at me and said, ʻYou        me tell you. See, thereʼs a very real, very
“Thatʼs not a bad idea. Do you know where        will not, under any circumstance, approve         serious disease where the vascular tissue
the “Noncovered” list came from?”                Hyperbaric Oxygen Therapy for stroke.ʼ”           breaks down in the brain with age. Creates
                                                 “Why not, I said. It works.”                      dementia, senility. What everybody now
David Freels:                                    “ʻI donʼt care,ʼ he said, ʻIʼm not going to let   calls Alzheimerʼs.”
“I donʼt know. The UHMS I guess.”                you do it.ʼ”
                                                 “But it works, I said. You know it works.”        David Freels:
Dr. Hart:                                        “ʻI donʼt care, he said, itʼll break the bank,    “Hyperbaric Oxygen Therapy works for
“Sort of. It came from a committee the           and Iʼm not going to let you do it. Youʼre        Alzheimerʼs?”
Social Security Administration put together      not going to approve this for stroke, and
back in the early 1970ʼs when they were          thatʼs an order.ʼ”                                Dr. Hart:
deciding what hyperbaric oxygen would be         “An order?” I asked.”                             “Of course it does. You just canʼt wait until
used for.”                                       “I was an officer in the United States Navy.       theyʼre blithering idiots before you give it
                                                 Iʼm retired now. I was given an order, and I      to them. Youʼve got to give it to them early
David Freels:                                    had to obey it.”                                  enough in the disease process. If you wait
“Really. How do you know that?”                                                                    until their brains are mush itʼs not going to
                                                 David Freels:                                     do them any good at all.”
Dr. Hart:                                        “What did he mean by ʻbreak the bankʼ?”
“I was chairman of the committee.”                                                                 David Freels:
                                                 Dr. Hart:                                         “Do you realize what youʼre telling
                                                 “He thought the country would go bankrupt         me? Youʼre telling me there really was
David Freels:                                    if we treated everybody who had a stroke.         somebody on the grassy knoll in Dallas.”
“Wow. Are you serious? Really?”                  At that time there were probably less than
                                                 a hundred chambers in the whole country.
                                                 Maybe just 30 or 40.”                             Dr. Hart:
Dr. Hart:                                        David Freels:                                     “Listen, I spent my entire career working

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     for the government. Anybody who works           Dr. Hart: “Exactly.”                            David Freels:
     for the government as long as I did can                                                         “That was 30 years ago. What if you spoke
     tell you stories like this. I donʼt care what   David Freels:                                   Congressional hearing, where your identity
     department or agency they work for.             “But the “Noncovered” list is just an off       was hidden and you were given some sort
     Everybody could tell you something like         label list?”                                    of, I donʼt know, protection. Immunity from
     what Iʼve just told you.”                                                                       whatever. I donʼt remember what they call
                                                     Dr. Hart: “True.”                               it. Whatever Oliver North was given.”
     David Freels:
     “Can you give me an affidavit. You know,         David Freels:                                   Dr. Hart:
     put into writing what you just told me.         “And 75% of all medications are prescribed      “Iʼll say something at the right time in the
     Weʼve got this hearing coming up, and I         off-label--”                                    right place, but not until then.”
     know what you just told me would be very
     helpful.”                                       Dr. Hart: “True.”                               David Freels:
                                                                                                     “Dr. Hart, I just called today to ask you
     Dr. Hart:                                       David Freels:                                   about your sickle cell research. Never in
     “No I wonʼt do that, and if anybody asks        “In pediatric neurology, itʼs right at 100%     a million years did I ever expect this. But
     me about what Iʼve just told you, Iʼll deny     of everything prescribed for brain-injured      look, Iʼve got a brain-injured kid. What
     every bit of it.”                               children is prescribed off-label.”              youʼve just told me, if I could bring back
                                                                                                     into our hearing what youʼve just told
     David Freels: “Why?”                            Dr. Hart: “Doesnʼt surprise me.”                me, weʼd win, hands down. Especially if
                                                                                                     youʼve got the documentation to back up
     Dr. Hart:                                       David Freels:                                   everything youʼve said, and I presume you
     “Look, I was given an order. If I violated      “Maybe you donʼt realize this, but when         do. Every brain-injured kid in the country
     that order I would have been guilty of          people see something on the “Noncovered”        would win. Every kid around the world,
     insubordination. I wasnʼt going to do           list, you know, the people in the hospitals     not to mention stroke, MS, & Alzheimerʼs.
     that. Instead, I agreed to serve on Social      where most of the chambers are, and             What youʼve just told me should be on
     Securityʼs Hyperbaric Oxygen Committee          they see that list coming from the federal      the cover of Time Magazine, Newsweek,
     only if they would let me put out the two       government, theyʼre not seeing that list        CBS, NBC, CNN, you name it. But if I
     lists: The covered list and the “Noncovered     as being off-label, they see it as illegal to   told anybody about this it would sound like
     indications.”                                   provide hyperbaric oxygen for any disease       something from the National Enquirer. You
                                                     on the “Noncovered” list. They literally        need to tell this story to somebody besides
     David Freels:                                   think they would be breaking a federal law      me.”
     “But what good does that do?”                   if they gave hyperbaric oxygen therapy to
                                                     somebody whoʼs had a stroke.” There was         Dr. Hart:
     Dr. Hart:                                       silence on the other end of the line.           “I will. When the time is right.”
     “They were going to approve it for what they    “Dr. Hart?”
                                                                                                     David Freels:
     were going to approve it for whether I was
                                                                                                     “So, can you still send me some stuff on
     on the committee or not. When they kept         Dr. Hart:
                                                                                                     sickle cell?”
     asking me to chair the committee, I insisted    “You may be right, but I canʼt help that.
     on the second list because I wanted people      Look Iʼve made it my lifeʼs work to prove
                                                                                                     Dr. Hart: “Sure.”
     to question why it wasnʼt approved for          Hyperbaric Oxygen Therapy works for as
     things beyond just the covered indications.     many things as I could on the “Noncovered”
                                                                                                     David Freels: “Well, thank you.”
     The only way I could guarantee that             list. Thatʼs been the primary focus of my
     questioning would take place was to create      research. I donʼt know what else I can do.”
                                                                                                     Dr. Hart:
     the second list, to spell it out. Hyperbaric
                                                                                                     “Remember. Iʼll deny this if anybody asks
     Oxygen Therapy has such a wide range of         David Freels:
                                                                                                     me.”
     uses I wanted people to say ʻwhy is it not      “Why donʼt you tell somebody what you
     covered for this when it works for that?”       just told me? This is a pretty amazing
                                                                                                     David Freels:
     David Freels: “Like sickle cell anemia?”        story, but Iʼm nobody. Why donʼt you sit
                                                                                                     “Well, if I tell anybody, just dontʼt sue
                                                     down with Mike Wallace on 60 Minutes or
                                                                                                     me.”
     Dr. Hart: “Yes.”                                something.”

     David Freels:                                   Dr. Hart:
     “And cerebral vascular insufficiency?”           “Iʼm not going to do that. I canʼt do that. I
                                                     had to follow orders.”

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